Have you considered that the FDA has to answer to Congress? with Time/Date on denials or approvals? # days, I suspect there may be some CYA occurring here also? This is Fact that Congress monitors FDA time on 510K reviews. I also realize that politics plays a serious part in appointments at the FDA. I feel there is a serious problem with the way our FDA is conducted both scientific and political.
Now the million $ question ..Do we need to have human clinical trial ...in that case we can not afford our own ..we will have to do some kind of partnership ...or massive dilution to fund these trails ...
Base on available information (clinicaltrial.gov) ...human clinical trail are required for devices like implants , mammography , disease detection ..etc ..I could not find any device similar to DVIS intended use went through human clinical trial ...
But I am not ruling out anything ...only thing that probability of human trail is very low ...
Worst case scenario is animal trail ...We will know the answer in next 2-3 weeks ...
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